Yutao HUA

The Vice President of Shanghai BiBo Biopharma Engineering Co., Ltd., formerly served as Director of the Department of Chemical Drugs and Medical Devices and the Department of Biological Resources and Safety at the China National Center for Biotechnology Development. In 2019, he was appointed by the Organization Department of the Communist Party of China as Director of Planning, Development, and Informatization at the Health Commission of Hainan Province.
His experience includes contributing to the drafting of the "Key Special Projects for New Drug Innovation" implementation plans, developing the strategic roadmaps for biomedicine and medical devices for the Ministry of Science and Technology, assisting in formulating the "National Biotechnology Development Strategy Outline," and leading revisions to the "Implementation Rules for the Administration of Human Genetic Resources" and the "14th Five-Year Plan for Health and Wellness in Hainan." Skilled in strategic planning, policy development, and corporate management.
Yutao Hua graduated from Tsinghua University with a MS in Microbiology.

John Lepore

John Lepore is an industry consultant specializing in small molecule process development, development quality systems, and regulatory strategy. Prior to his retirement from Merck (MSD) John Lepore was CMC and QbD practices lead for small molecules and led API process development for Merck synthetic compounds. In this role, he was responsible for process definition and optimization, including the application of appropriate phenomenological and empirical models with the goal of gaining technical understanding of API chemical processes, and enabling a science and risk based approach to API process development. During his 32-year career with Merck, John has led the API launch of nine products, operation of pilot plant facilities at Rahway, and the compliance function, encompassing safety, environmental, and GMP areas. With an in-depth knowledge of drug development and process and product economics, Dr. Lepore is a regular instructor for training of FDA staff (ORA), and a guest lecturer at both the University of Michigan (Pharmaceutical Engineering Program), and Rutgers University (Lerner Center for Pharmaceutical Management Studies). He serves on the ISPE PQLI Technical Steering Committee and was Chair of the Design Space Task Team. John received a Ph.D in Chemical and Biochemical Engineering at Rutgers University in New Brunswick, NJ, and a BS degree in Chemical Engineering from Worcester Polytechnic Institute.

谢 Sia镛福 Chong hock

Jerry ZHENG

郑磊明，毕业于华东理工大学制药工程专业，并获得硕士学位。目前，他在柯尔柏医药科技
（上海）有限公司担任董事总经理一职，主导该集团在中国的最高级别的管理事务，致力于
寻找新的商业机会，以实现销售和服务的快速扩展。
他在生命科学行业拥有超过二十年的深厚经验，尤其在研发、生产、中试、生产工艺、生产
设备以及自动化软硬件等领域具有丰富的知识和实践。他对制药和生物技术行业的全流程有
深入的理解，是生产数字化转型领域的权威专家。
在郑磊明的职业生涯中，他曾在 Harro Höfliger、罗克韦尔自动化等多家行业领先的企业担
任技术、销售、业务开发等高级管理职务，并凭借卓越的业绩多次获得表彰。自 2019 年 3
月起，他开始在柯尔柏医药科技中国区担任董事总经理。
他以出色的领导力和强烈的责任感，成功地制定并实施了公司的战略目标，带领团队取得了
突破性的发展，从而进一步扩大了公司在中国的销售和市场影响力。
Jerry Zheng, a Master's degree holder in Pharmaceutical Engineering from East China
University of Science and Technology, currently serves as the Managing Director of
Körber Pharma (Shanghai) Co., Ltd. He oversees the highest level of management affairs
of the Körber Business Area Pharma in China, committed to seeking new business
opportunities to achieve rapid expansion of sales and services.
He has more than twenty years of profound experience in the life sciences industry,
particularly in areas such as research and development, production, pilot production,
production processes, production equipment, and automation hardware and software. He
has an in-depth understanding of the entire process of the pharmaceutical and
biotechnology industry, as well as is an authoritative expert in the field of digital
transformation in production.
During Jerry's career, he has held senior management positions in technology, sales, and
business development in several industry-leading companies such as Harro Höfliger and
Rockwell Automation. He has been recognized multiple times for his outstanding
performance. Since March 2019, he has been serving as the Managing Director of Körber
Business Area Pharma in China.
With his excellent leadership and strong sense of responsibility, he successfully
formulated and implemented the company's strategic goals, leading the team to achieve
breakthrough development, thereby further expanding the company's sales and market
influence in China.

Yutao HUA

The Vice President of Shanghai BiBo Biopharma Engineering Co., Ltd., formerly served as Director of the Department of Chemical Drugs and Medical Devices and the Department of Biological Resources and Safety at the China National Center for Biotechnology Development. In 2019, he was appointed by the Organization Department of the Communist Party of China as Director of Planning, Development, and Informatization at the Health Commission of Hainan Province.
His experience includes contributing to the drafting of the "Key Special Projects for New Drug Innovation" implementation plans, developing the strategic roadmaps for biomedicine and medical devices for the Ministry of Science and Technology, assisting in formulating the "National Biotechnology Development Strategy Outline," and leading revisions to the "Implementation Rules for the Administration of Human Genetic Resources" and the "14th Five-Year Plan for Health and Wellness in Hainan." Skilled in strategic planning, policy development, and corporate management.
Yutao Hua graduated from Tsinghua University with a MS in Microbiology.

Shanshan LIU

Shanshan Liu is the current Technical Director at No deviation, responsible for the company's technology and innovation roadmap, as well as the professional growth of employees. She also sits on the Core Team, defining the company's international growth and business strategy. She received her M.Sc. in Biochemical Engineering from the University of Birmingham and brings an international perspective to her work from her experiences in various continents.
Throughout her 18-year career, Shanshan has held various technical roles within consulting firms and major pharmaceutical companies, including Novartis, where she worked within the Global Engineering organization and gained exposure to well established engineering and quality systems. With a solid technical background, Shanshan expanded her expertise into the Quality, Compliance, and Regulatory domains, where she has assisted pharmaceutical and medical device manufacturers in establishing quality systems, remediating quality, and compliance risks, and forming regulatory strategies. Through these projects, Shanshan has developed close collaborations with manufacturers, associations, and international regulators.
Shanshan is passionate about continued education and knowledge sharing. She has been serving as President of the ISPE Singapore Affiliate for the past years and is the current Chair of the ISPE APCA Council. She is also actively involved in other working groups, such as the Drug Shortage Initiative Team. To further share her knowledge, Shanshan is qualified as an ISPE instructor for various modules, i.e. C&Q and ATMP.

Ping ZHANG

Ping Zhang, currently Senior Vice President of Global Industrial Affairs at Hepalui, holds an MBA degree and international work and study experience. Previously, he served as the Head of Sanofi Industrial Affairs in China, responsible for Sanofi's industrial operations in China, and led the implementation of several new products and group product transfer projects in China. Prior to that, he worked for Xi 'an Janssen Pharmaceutical Company, one of the first foreign-invested enterprises in China. Zhang Ping has more than 30 years of experience in drug production management in foreign-funded enterprises and has obtained the first Six Sigma Black belt certification in China.

Maurice B. Parlane

Maurice Parlane is Principal of New Wayz Consulting Ltd in New Zealand and a Director of CBE Pty Ltd in Australia. He is a professional engineer with 30 years’ experience within the biopharmaceutical industry, including 20 years as an industry consultant providing support to manufacturing and compliance management; validation and operational excellence projects in Australasia and the Asia Pacific region. Prior to this, he held senior engineering and manufacturing roles within the Glaxo group of companies. He has a Bachelor of Manufacturing Technology (Hons) as well as mechanical and electrical engineering qualifications. Maurice is past president and current director of the ISPE Australasian Affiliate. He is the co-lead of ISPE’s Asia Pacific Regulatory and Quality Harmonization committee and leader of the Process Validation Team and is a member of the Guidance Documents Committee. He is an ISPE PV Instructor and was named ISPE Member of the year in 2016. He is currently serving as the Leader of the ISPE Process Validation Team.

Christian Wölbeling

Christian Wölbeling is a seasoned ISPE member with 25 years of experience. He currently serves as Chair of the ISPE Pharma 4.0™ Community of Practice and is actively involved in the GAMP® and Process Analytical Technology (PAT) Communities of Practice. A recognized expert in pharmaceutical digitalization, Christian has contributed to several ISPE guides, including the GAMP® Guide: Records and Data Integrity and the APQ Guide: Process Performance and Product Quality Monitoring System. He is currently leading a team to develop an ISPE guidance document on Pharma 4.0™.
With over 30 years at Körber, Christian now holds the position of Executive Industry Advisor and Senior Strategic Account Manager, based in Lüneburg, Germany. A pioneer in pharmaceutical digitalization, he joined Werum Software & Systems (now part of Körber) in 1992, where he led the development of production management software for top pharmaceutical companies such as Bayer, Novartis, and AstraZeneca. In 2015, he co-created the Pharma 4.0™ concept with Marcel Staudt, bridging Industry 4.0 automation with pharmaceutical ICH guidelines to drive digital transformation in the industry.
Christian believes that breaking silos between quality, operations, and engineering enables data-driven control strategies, accelerating therapeutic innovation and optimizing production processes for the benefit of patients. His work has had a profound impact on the digitalization and automation of the pharmaceutical industry.
Christian Wölbeling 是ISPE的资深成员，拥有25年的会龄。他现任ISPE Pharma 4.0™实践社区主席，并积极参与GAMP®和过程分析技术（PAT）实践社区的工作。Christian 在制药行业数字化领域具有丰富经验，曾参与编写多部ISPE指南，包括《GAMP®指南：记录与数据完整性》和《APQ指南：过程性能与产品质量监控系统》。目前，他正领导团队制定关于Pharma 4.0™的ISPE指导文件。
Christian 在柯尔柏工作超过30年，现任执行行业顾问和高级战略客户经理，常驻德国吕讷堡。作为制药行业数字化的先驱，他于1992年加入维隆软件与系统公司（现为柯尔柏集团的成员公司），主导开发了多项制药生产管理软件，客户包括拜耳、诺华、阿斯利康等全球顶级制药企业。2015年，他与Marcel Staudt共同提出Pharma 4.0™概念，旨在将工业4.0的自动化理念与制药行业特有的ICH指南相结合，推动制药行业的数字化转型。
Christian 坚信，通过打破质量、运营和工程之间的壁垒，制药企业可以实现数据驱动的整体控制策略，加速治疗创新并优化生产流程，最终造福患者。他的工作对制药行业的数字化和自动化发展产生了深远影响。

Shanti Marlina Sibuea

Shanshan LIU

Shanshan Liu is the current Technical Director at No deviation, responsible for the company's technology and innovation roadmap, as well as the professional growth of employees. She also sits on the Core Team, defining the company's international growth and business strategy. She received her M.Sc. in Biochemical Engineering from the University of Birmingham and brings an international perspective to her work from her experiences in various continents.
Throughout her 18-year career, Shanshan has held various technical roles within consulting firms and major pharmaceutical companies, including Novartis, where she worked within the Global Engineering organization and gained exposure to well established engineering and quality systems. With a solid technical background, Shanshan expanded her expertise into the Quality, Compliance, and Regulatory domains, where she has assisted pharmaceutical and medical device manufacturers in establishing quality systems, remediating quality, and compliance risks, and forming regulatory strategies. Through these projects, Shanshan has developed close collaborations with manufacturers, associations, and international regulators.
Shanshan is passionate about continued education and knowledge sharing. She has been serving as President of the ISPE Singapore Affiliate for the past years and is the current Chair of the ISPE APCA Council. She is also actively involved in other working groups, such as the Drug Shortage Initiative Team. To further share her knowledge, Shanshan is qualified as an ISPE instructor for various modules, i.e. C&Q and ATMP.

Christoph Herwig

Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to entering his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. From 2008 to 2023, he was a full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec, which is now part of Körber Pharma Austria, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently acts as senior scientific advisor for Körber.

Christoph Herwig，生物过程工程师，毕业于亚琛工业大学（RWTH Aachen），在进入瑞士洛桑联邦理工学院（EPFL）攻读跨学科生物过程识别博士学位之前，曾在工业界从事大型化工设施的设计和调试工作。随后，他将自己的职业定位在生物制药行业的生物过程开发与设施设计之间的交叉领域。从2008年到2023年，他担任维也纳工业大学（Vienna University of Technology）生物化学工程的全职教授，研究领域主要集中在开发生物制药过程中基于过程分析技术（PAT）和质量源于设计（QbD）原则的数据科学方法，以实现集成和高效的生物过程开发。2013年，他创立了Exputec公司，该公司现已成为柯尔柏医药科技奥地利公司的一部分，致力于为生物制药生命周期提供领先的数据科学软件解决方案。目前，Christoph Herwig在柯尔柏担任高级科学顾问。

Jerry ZHENG

郑磊明，毕业于华东理工大学制药工程专业，并获得硕士学位。目前，他在柯尔柏医药科技
（上海）有限公司担任董事总经理一职，主导该集团在中国的最高级别的管理事务，致力于
寻找新的商业机会，以实现销售和服务的快速扩展。
他在生命科学行业拥有超过二十年的深厚经验，尤其在研发、生产、中试、生产工艺、生产
设备以及自动化软硬件等领域具有丰富的知识和实践。他对制药和生物技术行业的全流程有
深入的理解，是生产数字化转型领域的权威专家。
在郑磊明的职业生涯中，他曾在 Harro Höfliger、罗克韦尔自动化等多家行业领先的企业担
任技术、销售、业务开发等高级管理职务，并凭借卓越的业绩多次获得表彰。自 2019 年 3
月起，他开始在柯尔柏医药科技中国区担任董事总经理。
他以出色的领导力和强烈的责任感，成功地制定并实施了公司的战略目标，带领团队取得了
突破性的发展，从而进一步扩大了公司在中国的销售和市场影响力。
Jerry Zheng, a Master's degree holder in Pharmaceutical Engineering from East China
University of Science and Technology, currently serves as the Managing Director of
Körber Pharma (Shanghai) Co., Ltd. He oversees the highest level of management affairs
of the Körber Business Area Pharma in China, committed to seeking new business
opportunities to achieve rapid expansion of sales and services.
He has more than twenty years of profound experience in the life sciences industry,
particularly in areas such as research and development, production, pilot production,
production processes, production equipment, and automation hardware and software. He
has an in-depth understanding of the entire process of the pharmaceutical and
biotechnology industry, as well as is an authoritative expert in the field of digital
transformation in production.
During Jerry's career, he has held senior management positions in technology, sales, and
business development in several industry-leading companies such as Harro Höfliger and
Rockwell Automation. He has been recognized multiple times for his outstanding
performance. Since March 2019, he has been serving as the Managing Director of Körber
Business Area Pharma in China.
With his excellent leadership and strong sense of responsibility, he successfully
formulated and implemented the company's strategic goals, leading the team to achieve
breakthrough development, thereby further expanding the company's sales and market
influence in China.